Quality Assurance Specialist - Document Control Coordinator

Rotating Shifts Every 6 Months (Day, Swing, or Night)

Key Details:

• Shift Schedule:
• Day Shift: 7 AM – 8 PM
• Swing Shift: 1 PM – Midnight
• Night Shift: 7 PM – 8 AM
• Shift rotation every 6 months based on business needs.

Role Overview:

As a Quality Assurance Specialist, you will provide daily oversight and compliance support to Manufacturing and Facilities & Engineering teams. Under general supervision, your responsibilities will include:

• Monitoring processes, procedures, and quality systems to ensure compliance.
• Conducting on-the-floor quality oversight and reviewing electronic batch records.
• Revising and approving Standard Operating Procedures (SOPs), work orders, and minor deviations.
• Evaluating compliance issues, providing recommendations, and ensuring timely resolution of quality records.
• Representing the Quality Assurance team in departmental projects and achieving operational goals in a collaborative, matrixed team environment.

Preferred Qualifications:

• Bachelor’s degree in Biochemistry, Biology, Chemistry, or a related scientific field.
• Proven experience with GMP operations, including SOP adherence, training, and documentation practices.
• Proficiency in evaluating documentation and operational processes against company procedures.
• Familiarity with Quality Systems, and excellent organizational skills to manage multiple tasks effectively.
• Strong written and verbal communication skills, with the ability to work independently and as part of a team.
• Leadership attributes with a track record of driving process improvements and initiatives.